NOW APPROVED in R/M HNSCC
The first and only subcutaneous dual-targeted therapy for patients with R/M HNSCC1,2
RYBREVANT FASPRO is indicated as a single agent for the treatment of adult patients with R/M HNSCC with disease progression on or after platinum-based chemotherapy and an anti–PD-(L)1 antibody.1
Not indicated as a treatment for patients with OPSCC that is HPV-associated (ie, by p16 IHC).1
This indication is approved under accelerated approval. Continued approval for this indication may be contingent on confirmatory trial(s).1
Duration of response1,3
56% (24/43)
of responders maintained their response for
≥6months†
Duration of response ranged from 1.4+ to 19.7+ months"+" indicates ongoing response.
Study design: The multi-cohort, multicenter, open-label, ongoing phase 1b/2 OrigAMI-4 trial (N=102) evaluated the efficacy and safety of subcutaneous RYBREVANT FASPRO in patients with previously treated R/M HNSCC who have received platinum-based chemotherapy and an anti–PD-(L)1 antibody. Patients were excluded from the trial if they had OPSCC that was HPV-associated (ie, by p16 IHC). Primary endpoint: ORR; secondary endpoint: DOR, both per BICR.1,3
*BICR-assessed confirmed ORR per RECIST v1.1 was 42% (95% CI: 32, 52).1
†DOR was assessed by BICR per RECIST v1.1.1
Download a helpful guide for navigating access to RYBREVANT FASPRO, now with a permanent J-Code:
J9062
Effective July 1, 2026
Download a guide with comprehensive dosing, administration, and
prophylactic strategies for RYBREVANT FASPRO.
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BICR, blinded independent central review; CI, confidence interval; CR, complete response; DOR, duration of response; HPV, human papillomavirus; IHC, immunohistochemistry; OPSCC, oropharyngeal squamous cell carcinoma; ORR, overall response rate; PD-(L)1, programmed cell death (ligand) protein 1; PR, partial response; RECIST, Response Evaluation Criteria in Solid Tumors; R/M HNSCC, recurrent or metastatic head and neck squamous cell carcinoma.
References: 1. RYBREVANT FASPRO [Prescribing Information]. Horsham, PA: Janssen Biotech, Inc. 2. National Cancer Institute. Drugs approved for head and neck cancer. Updated May 8, 2025. Accessed September 1, 2026. https://www.cancer.gov/about-cancer/treatment/drugs/head-neck 3. Burtness B, Rosenberg AJ, Calderon B, et al; OrigAMI-4 Cohort 1 Investigators. Amivantamab in recurrent/metastatic head and neck squamous cell cancer after checkpoint inhibitor and chemotherapy: pivotal results from the phase Ib/II OrigAMI-4 study. J Clin Oncol. 2026:1-7. doi:10.1200/JCO-26-01042